Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The United States Food and Drug Administration (FDA) has posted a medical device safety alert concerning its Berlin Heart GmbH EXCOR Pediatric Ventricular Assist Device Blood Pumps [Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump); P25P-001x01 (25 ml blood pump); P30P-001x01 (30 ml blood pump), P50P-001 (50 ml blood pump); P60P-001 (60 ml blood pump)][HKMD No.: 180212].
According to the FDA, there is a potential for a disruption in one or more of the triple layer membranes of the ventricular assist device.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=92132
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 29 May 2023